Actively Recruiting
Advancing Diagnosis and Treatment of Pediatric Asthma
Led by Luxembourg Institute of Health · Updated on 2026-03-30
208
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
L
Luxembourg Institute of Health
Lead Sponsor
L
Luxembourg National Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Asthma is one of the most common chronic diseases in children, and treatment success often depends on proper inhaler use and consistent medication adherence. Exposure to allergens and pollutants can also impact treatment response and asthma control. Moreover, there is a growing need for non-invasive biomarkers to support better diagnosis and personalized care. The goal of this clinical trial is to investigate if a new digital inhaler can improve inhalation technique and treatment adherence in children aged 5 to 16 years old, with partly controlled or uncontrolled asthma requiring treatment with inhaled corticosteroids. The main questions it aims to answer are: * Does the use of a digital inhaler improve adherence to inhaled corticosteroids and asthma control in children? * Which biomarkers could support diagnosis and help predict treatment responses in children with asthma? * How do environmental factors influence asthma control and treatment outcomes? Researchers will compare adherence to inhaled corticosteroid therapy between children using a new digital inhaler (Whizz spacer) and those using a standard, non-digital inhaler (AeroChamber Plus® Flow-Vu®) to see if the digital inhaler improves treatment administration and asthma control. They will quantify inflammatory markers in biological samples from asthmatic children and children without respiratory disease, to find biomarkers linked to disease and treatment response. Participants will: * Use the Whizz spacer or the AeroChamber Plus® Flow-Vu® during 12 weeks for corticosteroid inhalation, and complete daily a study diary to follow treatment administration. * Complete asthma control and quality of life questionnaires and have an evaluation of asthma control through GINA score at baseline, 6 and 12 weeks. * Undergo spirometry tests and FENO measurements at baseline and 12 weeks. * Give biological samples at baseline and 12 weeks. * Collect children's bedroom dust samples at baseline. * Wear a bracelet for 7 days at baseline and 12 weeks to monitor physical activity.
CONDITIONS
Official Title
Advancing Diagnosis and Treatment of Pediatric Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 16 years, any gender
- Doctor's diagnosis of asthma requiring treatment with inhaled corticosteroids or inhaled corticosteroids plus long-acting beta-agonists via metered dose inhaler
- Partly controlled or uncontrolled asthma based on GINA criteria
- Signed informed consent by legal guardian and assent from children aged 10 years or older
You will not qualify if you...
- Severe asthma attack treated with systemic corticosteroids in the past 2 weeks or active respiratory infection
- Diagnosis of other chronic lung diseases such as COPD or cystic fibrosis
- Severe asthma as defined by GINA
- Severe underlying conditions like serious congenital heart disease or cancer
- Immune deficiency or receiving immunosuppressive treatments
- Receiving immunotherapy (for participants in Luxembourg donating samples)
- Neurological disorders or cognitive impairment
- Having a sibling already enrolled in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Luxembourg Research Clinic (LRC)
Luxembourg, Luxembourg
Actively Recruiting
Research Team
C
Christiane Hilger, PhD
CONTACT
A
Ali Znati
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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